ADVIL 200 MG TABLETS

Main information

  • Trade name:
  • ADVIL 200 MG TABLETS
  • Dosage:
  • 200 Milligram
  • Pharmaceutical form:
  • Coated Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ADVIL 200 MG TABLETS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0172/029/001
  • Authorization date:
  • 31-10-1997
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995,asamended

MedicinalProducts(ControlofPlacingontheMarket)Regulations,2007,asamended

PA0172/029/001

CaseNo:2086521

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

PfizerConsumerHealthcareLtd

RamsgateRoad,Sandwich,Kent,CT139NJ,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Advil200mgTablets

theparticularsofwhicharesetoutintheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsasmaybespecifiedin

thesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom28/07/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Advil200mgTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

EachtabletcontainsIbuprofen200mg.

Excipients:Alsocontainssucrose,methylparahydroxybenzoate(E218)+propylparahydroxybenzoate(E216)

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Coatedtablet(tablet)

Apinkishbrown,sugarcoatedtabletwith‘Advil’printedinblackononeside.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Shorttermmanagementofpainandfeverconditionssuchas:

Acutepainfromdysmenorrhoea.

Dentalpain.

Muscularpain.

Headaches.

Coldsandflusymptoms.

Backache.

4.2Posologyandmethodofadministration

Adults,theelderlyandyoungpersonsovertheageof12:

1to2tabletsevery4-6hours.

Donotexceed6tabletsin24hours.

Donotgivetochildrenunder12.

Elderly:

Non-steroidalanti-inflammatorydrugs(NSAIDs)shouldbeusedwithparticularcautioninelderlypatientswhoare

pronetoadverseevents.Thelowestdosecompatiblewithadequatesafeclinicalcontrolshouldbeemployed.

SeealsoSection4.4.

4.3Contraindications

Useinpatientsallergictoanyoftheingredients.

Useinpatientshypersensitivetoaspirinorwithbronchospasm,asthma,rhinitisorurticariaassociatedwithnon-

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Historyofgastrointestinalbleedingorperforation,relatedtopreviousNSAIDstherapy.Activeorhistoryor

recurrentpepticulcer/haemorrhage

(twoormoredistinctepisodesofprovenulcerationsorbleeding)

Useinchildrenunder12years.

Patientswithsevereheartfailure.

Donotuseinthelast3monthsofpregnancy

4.4Specialwarningsandprecautionsforuse

TheuseofAdvil200mgtabletswithconcomitantNSAIDsincludingcyclooxygenase-2selectiveinhibitors

shouldbeavoided.

Undesirableeffectsmaybeminimizedbyusingtheminimumeffectivedosefortheshortestdurationnecessary

tocontrolsymptoms.

Elderly:TheelderlyhaveanincreasedfrequencyofadversereactionstoNSAIDsespeciallygastrointestinal

bleedingandperforationwhichmaybefatal(seesection4.2).

Gastrointestinalbleeding,ulcerationandperforation:GIbleeding,ulcerationofperforation,whichcanbefatal,

hasbeenreportedwithallNSAIDsatanytimeduringtreatment,withorwithoutwarningsymptomsoraprevious

historyofseriousGUevents.

TheriskofGIbleeding,ulcerationorperforationishigherwithincreasingNSAIDdoses,inpatientswitha

historyofulcer,particularlyifcomplicatedwithhaemorrhageorperforation(seesection4.3),andintheelderly.

Thesepatientsshouldcommencetreatmentonthelowestdoseavailable.Combinationtherapywithprotective

agents(e.g.misoprostolorprotonpumpinhibitors)shouldbeconsideredforthesepatientsandalsoforpatients

requiringconcomitantlowdoseaspirinorotherdrugslikelytoincreasegastrointestinalrisk(seebelowand4.5).

PatientswithahistoryofGItoxicity,particularlywhenelderly,shouldreportanyunusualabdominalsymptoms

(especiallyGIbleeding)particularlyintheinitialstagesoftreatment.

Cautionshouldbeadvisedinpatientsreceivingconcomitantmedicationswhichcouldincreasetheriskof

ulcerationorbleedingsuchasoralcorticosteroids,anticoagulantssuchaswarfarin,selectiveserotonin-reuptake

inhibitorsoranti-plateletagentssuchasaspirin(seesection4.5).

WhenGIbleedingorulcerationoccursinpatientsreceivingAdvil200mgtablets,thetreatmentshouldbe

withdrawn.

NSAIDsshouldbegivenwithcaretopatientswithhistoryofgastrointestinaldisease(ulcerativecolitis,Crohn's

disease)astheirconditionmaybeexacerbated(seesections4.8-undesirableeffects).

Attheoutsetoftreatment,monitoringoftheurinevolumeandrenalfunctionisnecessaryincardiac

insufficiency,cirrhoticandnephroticpatients,inpatientstakingadiureticandinthosewithchronicrenal

insufficiency.TheuseofNSAIDsshouldpreferablybeavoidedinpatientswithpre-existingrenaldiseaseor

volumedepletion.

Patientswhoarepregnant,elderlyorsufferingfromasthmaorrenal,orhepaticinsufficiencyshouldconsulttheir

doctor.

Caution(discussionwithdoctororpharmacist)isrequiredpriortostartingtreatmentinpatientswithahistoryof

hypertensionand/orheartfailureasfluidretentionandoedemahavebeenreportedinassociationwithNSAID

theory.Undesirableeffectsmaybeminimisedusingthelowesteffectivedosefortheshortestdurationnecessary

tocontrolsymptoms(seeGIcardiovascularrisksbelow).

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ClinicaltrialandepidemiologicaldatasuggestthatuseofsomeNSAIDs(particularlyathighdoses(2400mgdaily)and

inlongtermtreatment)maybeassociatedwithasmallincreasedriskofarterialthromboticevents(forexample

myocardialinfarcationorstroke). Overall,epidemiologicalstudiesdonotsuggestthatlowdoseibuprofen

(e.g=1200mgdaily)isassociatedwithanincreasedriskofmyocardialinfarcation.

Seriousskinreactions,someofthemfatal,includingexfoliativedermatitis,Stevens-Johnsonsyndromeandtoxic

epidermalnecrolysis,havebeenreportedveryrarelyinassociationwiththeuseofNSAIDs(see4.8).Patientsappearto

beathighestriskofthesereactionsearlyinthecourseoftherapy,theonsetofthereactionoccurringinthemajorityof

caseswithinthefirstmonthoftreatment.Advil200mgtabletsshouldbediscontinuedofcaseswithinthefirstmonthof

treatment.Advil200mgtabletsshouldbediscontinuedatthefirstappearanceofskinrash,mucosallesions,orany

othersignofhypersensitivity.

Thereissomeevidencethatdrugswhichinhibitcyclo-oxygenase/prostaglandinsynthesismaycauseimpairmentof

femalefertilitybyaneffectofovulation.Thisisreversibleonwithdrawaloftreatment.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ItisconsideredunsafetotakeNSAID'sincombinationwithwarfarinorheparinunlessunderdirectmedical

supervision.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.However,thelimitationsofthesedataandtheuncertaintiesregardingextrapolationofex

vivodatatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofenuse,andno

clinicallyrelevanteffectisconsideredtobelikelyforoccasionalibuprofenuse(seesection5.1).

Careshouldbetakeninpatientstreatedwithanyofthefollowingdrugsasinteractionshavebeenreported:

Anti-hypertensives: Reducedanti-hypertensiveeffect.

Diuretics: Reduceddiureticeffect.DiureticscanincreasetheriskofnephrotoxicityofNSAIDs.

Cardiacglycosides: NSAIDsmayexacerbatecardiacfailure,reduceGFRandincreaseplasmacardiacglycoside

levels.

Lithium: Decreasedeliminationoflithium.

Methotrexate: Decreasedeliminationofmethotrexate.

Cyclosporin: IncreasedriskofnephrotoxicitywithNSAIDs.

OtherNSAID's: AvoidconcomitantuseoftwoormoreNSAIDs.

Corticosteroids: Increasedriskofgastrointestinalbleedingandulceration(seesection4.4).

Aminoglycosides: Reductioninrenalfunctioninsusceptibleindividualsdecreasedeliminationofaminoglycoside

andincreasedplasmaconcentrations.

Probenecid: ReductioninmetabolismandeliminationofNSAIDandmetabolites.

Oralhypoglycaemic

agents: Inhibitionofmetabolismofsulfonylureadrugs,prolongedhalf-lifeandincreasedriskof

hypoglycaemia.

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Anti-plateletagentsandselectiveserotoninreuptakeinhibitors(SSRIs):increasedriskofgastrointestinalbleeding(see

section4.4).

4.6Pregnancyandlactation

Althoughnoteratogeniceffecthasbeenreportedintheliterature,itisrecommended,asforallNSAIDs,notto

administeribuprofenduringthefirsttrimester.

Theonsetoflabourmaybedelayedandthedurationoflabourmaybeincreased,soibuprofenshouldnotbeused

towardstheendofthethirdtrimester.

Ibuprofenappearsinbreastmilkinverylowconcentrationsandisunlikelytoaffectthebreast-fedinfantadversely.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Gastrointestinal:themostcommonobservedadverseeventsaregstrointestinalinnature.Pepticulcers,perforationor

GIbleeding,sometimesfatalintheelderly,mayoccur(seesection4.4).Nausea,vomiting,diarrhoea,flatulence,

constipation,dyspepsia,abdominalpain,melaena,haematemesis,ulcerativestomatitis,exacerbationofcolitisand

Crohn'sdisease(seesection4.4-Specialwarningsandprecautionsforuse)havebeenreportedfollowing

administration.Lessfrequently,gastritishasbeenobserved.

Skin:Rashes,pruritus,fluidbuildupinthetissuebelowtheskinandinthemucousmembraneswhichappearasspots

orlumps,bloodblistersandoccasionallyflakingoftheskin.

Haematological:Mostfrequentlytheblooddoesnotclotaswellwhichmayresultineasybruisingorbleedingand

occasionallyanaemia.Thrombocytopenia,occasionallyagranulocytosisandaplasticanaemiahavealsobeenreported.

Kidney:Bloodintheurine,kidneydamageandkidneyfailureshavebeenreported.

Breathing:Wheezingandbreathingdifficultiesmaybetriggeredinpatientssufferingfromorwithprevioushistoryof

bronchialasthmaorallergicdisease.

Liver:Abnormalliverfunctiontests,jaundice,inflammationoftheliverandoccasionalliverfailure.

Inaddition,fluidretentionandweightgain,headache,ringingintheear,dizzinessandvertigo,visualdisturbances,

depression,confusion,hallucinationsandgeneralisedallergicreactionsincludingsuddencollapsehavebeenreported.

BullousreactionsincludingStevens-Johnsonsyndromeandtoxicepidermalnecrolysis(veryrare).

Clinicaltrialandepidemiologicaldatasuggesttheuseofibuprofen(particularlyathighdoses2400mgdaily)andin

longtermtreatmentmaybeassociatedwithasmallincreasedriskofarterialthromboticevents(forexample

myocardialinfarctionorstroke)(seesection4.4).

Oedema,hypertensionandcardiacfailurehavebeenreportedinassociationwithNSAIDtreatment.

4.9Overdose

Symptomsincludeheadache,vomiting,drowsinessandhypotension.Hyperkalaemiamaydevelop.

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pressurefollowingoverdose.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Ibuprofenisanon-steroidalanti-inflammatoryagentofthepropionicacidgroup.Ithasanalgesic,antipyreticandanti-

inflammatoryproperties.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.Inonestudy,whenasingledoseofibuprofen400mgwastakenwithin8hbeforeorwithin

30minafterimmediatereleaseaspirindosing(81mg),adecreasedeffectofASAontheformationofthromboxaneor

plateletaggregationoccurred.However,thelimitationsofthesedataandtheuncertaintiesregardingextrapolationof

exvivodatatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofenuse,andno

clinicallyrelevanteffectisconsideredtobelikelyforoccasionalibuprofenuse.

5.2Pharmacokineticproperties

Absorption:

Ibuprofenis99%proteinboundandithasaneliminationhalf-lifeofabouttwohours.

Distribution:

Theshortplasmahalf-lifedoesnotleadtoaccumulationphenomena.Ibuprofenappearsinbreastmilkinlow

concentrationsandisunlikelytoaffectthebreast-fedinfantadversely.

Metabolism:

Ibuprofendoesnothaveanyenzyme-inducingeffect.Itis90%metabolisedintheliverto2-Hydroxyibuprofenand2-

Carboxyibuprofen.

Excretion:

Themetabolitesareexcretedintheurinealongwithapproximately9%ofunchangeddrug.

Elderly:

Agehasnosignificanteffectonthekineticsofibuprofen.

5.3Preclinicalsafetydata

Asawell-establishedandwidelyusedingredient,thepreclinicalsafetyofibuprofeniswelldocumented.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Maizestarch

Pregelatinisedstarch

Colloidalanhydroussilica

Stearicacid

Cornstarchgrade826

Croscarmellosesodium

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Microcrystallinecellulose

Carnaubawax

Sucrose

OpaluxBrownAS-R-9030-A

Sucrose

Titaniumdioxide(E171)

Redironoxide(E172)

Povidone(E1201)

Sodiumbenzoate(E211)

Methylparahydroxybenzoate(E218)

Propylparahydroxybenzoate(E216)

OpaglossRegularGS-2-0310

Pharmaceuticalshellac

Povidone

Acetylatedmonoglyceride

OpacodeBlack–S-1-8152HV

Shellac

Blackironoxide(E172)

SoyalecithinMCthin

AntifoamDC1510

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

APVC,PE,PVDC,paper/aluminiumfoilblisterpackcontaining2,4,10or20tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

PfizerConsumerHealthcareLtd

RamsgateRoad

Sandwich

Kent

CT139NJ

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8MARKETINGAUTHORISATIONNUMBER

PA172/29/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:09July1997

Dateoflastrenewal: 09July2007

10DATEOFREVISIONOFTHETEXT

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